Cardio Xp
510(k) K102767
Cardio Xp is a medical device (FDA Class II; FDA product code DPS, Electrocardiograph) made by Bionet Co., Ltd., cleared under FDA 510(k) K102767 on 3 Jun 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102767 | Date3 Jun 2011 | StatusActive |
Official records
- FDA 510(k) database K102767
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DPS
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K102767
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CardioXP | CardioXP | 08809276940285 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code DPS (Electrocardiograph).
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- HeRO duet 3.1 by Medical Predictive Science Corp.
- ELI PC Electrocardiograph by MORTARA INSTRUMENT, INC.
- Mediblu ECG System by Mediblu Medical, LLC
- Biovision Cardiac Strobe by Cardiac Imaging
- Multiscriptor EK Various #43 by Litton Medical Electronics
- Cardiofax CE Model PEA-1110K by NIHON KOHDEN AMERICA, INC.
- Isolated Electrocardiograph Model 1207 by Electronics For Medicine, Inc.